GMP and ISO standards: Galenika's passport to competitiveness on the global market

Pharmaceutical Quality System has become an inevitable element in increasing competitiveness and survival of the organization in the global pharmaceuticals market

Galenika is a responsible company oriented towards the future. Galenika has established quality systems that it continuously renews by implementing new requirements of internationally recognized standards. According to the best practice, an effective quality management system in Galenika is adopted through implementation of GMP guidelines, ISO and HACCP standards.

Galenika is committed to the consistent implementation of the highest business standards in order to ensure the highest level of product quality and safety.

EU GMP certificate for the Factory of solid pharmaceutical preparations obtained in 2017
GMP certificate of the Russian Federation for all products registered in this country
GMP certificate for all drug production facilities issued by the Ministry of Health of Serbia
The GMP compliance of the Quality Control was also confirmed by a check by the contractual partners
ISO 9001:2015 standard that Galenika applies in the processes of design, production, installation and servicing of products in accordance with user requirements and legal regulations.
HACCP certificate for the production of high-quality dietary products.

Our certificates

We have also completed re-certification according to HACCP standard for dietary supplements as well as change of Certification company.

Product quality and safety policy